SIST EN ISO 8836:2020

Name: SIST EN ISO 8836:2020 — Suction catheters for use in the respiratory tract (ISO 8836:2019)
SKU: SIST EN ISO 8836:2020
Price: 57600 RUB
Availability: InStock

Suction catheters for use in the respiratory tract (ISO 8836:2019)

Название (английский):

Suction catheters for use in the respiratory tract (ISO 8836:2019)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 32
Дата публикации:: 12 ноября 2020 г.
ICS:: 11.040.10
Технический комитет:: VAZ - Healthcare

Тип поставки:

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Цена:57 600 ₽

Описание (английский):

This document specifies dimensions and requirements for both open and closed suction catheters made of flexible materials and intended for use in suctioning of the respiratory tract. Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this document. NOTE For guidance on airway management during laser surgery of the upper airway, see ISO/TR 11991[4].

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 8836:2020 (ISO 8836:2019) specifies dimensions, design and performance requirements for suction catheters for use in the respiratory tract, covering both open and closed suction catheters made of flexible materials. The standard is intended to help manufacturers, clinicians and testing laboratories ensure safe, interoperable suction catheter products. Suction catheters intended for use with flammable anaesthetic agents, lasers or electrosurgical equipment are excluded.

Key topics and technical requirements

Scope and definitions - clear terminology for patient end, machine end, closed suction catheter, manifold, eye, etc.

Materials - general requirements for materials used in catheter shafts, sleeves and connectors (biocompatibility and suitability for respiratory use).

Design requirements

Size designation and dimensions to assist clinicians in selecting catheters compatible with tracheal or tracheostomy tubes.
Catheter tip and eye (side holes) design considerations.
Connectors - requirements for suction catheter connectors; both male and female connector types are addressed (female connector was reinstated in this edition).
Closed suction system components - manifold, protective sleeve, suction control device, flushing system and T-piece port requirements.

Performance requirements

Security of construction and attachment tests.
Shaft performance (flexibility, strength).
Suction control device performance, leakage and resistance to flow testing methods.
Conditions for measurement of residual vacuum in closed systems.

Sterile supply, packaging and labelling - requirements for devices supplied sterile, packaging integrity and manufacturer information, including marking and instructions for use (IFU).

Normative and informative annexes - test methods, rationale and hazard identification to support risk assessment.

Applications and who uses this standard

Medical device manufacturers - to design and certify open and closed suction catheters that meet European and international requirements.

Regulatory and quality teams - for conformity assessment, technical file preparation and compliance with CEN/ISO requirements.

Clinical engineering / procurement - to select appropriate catheter sizes and closed suction systems for ICUs, anaesthesia and respiratory care.

Testing laboratories - to perform the normative tests specified (leakage, residual vacuum, security of attachment).

Healthcare professionals - guidance on device selection and intended use related to airway management.

Related standards

ISO 5356-1 (Conical connectors)

ISO 5367 (Breathing sets and connectors)

ISO 18190 (General requirements for airways and related equipment)

ISO 18562-1 (Biocompatibility of breathing gas pathways)

ISO 80369-7 (Small-bore connectors)

ISO/TR 11991 (Airway management during laser surgery)

Keywords: EN ISO 8836:2020, ISO 8836:2019, suction catheters, open suction catheter, closed suction catheter, respiratory tract, catheter dimensions, catheter connectors, medical device standard.

SIST EN ISO 8836:2020

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 8836:2019

Suction catheters for use in the respiratory tract

ISO 5356-1:2015

Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets

SIST EN ISO 5367:2023

Anaesthetic and respiratory equipment - Breathing sets and connectors (ISO 5367:2023)

BS ISO 18190:2025-TC

Tracked Changes. Anaesthetic and respiratory equipment. General requirements for airway devices and related e…

SIST EN ISO 18562-1:2024

Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and tes…

SIST EN ISO 80369-7:2021

Small-bore connectors for liquids and gases in healthcare applications - Part 7: Connectors for intravascular…

ISO/TR 11991:1995

Guidance on airway management during laser surgery of upper airway